Effects of Transcutaneous Perineal Stimulation Versus Anal Stimulation

Not Applicable

Completed

• Conditions: Urinary Incontinence; Radical Prostatectomy; Pelvic Floor
• Interventions: Other: Anal stimulation; Other: Transcutaneous perineal stimulation

• Registration Number: NCT03587402
• Lead Sponsor: RAPbarcelona

Brief Summary

This study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy.

Half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.

Detailed Description

Pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. Perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention.

The perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. The two techniques are commonly used. Each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.

Study Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-16
• Study Start: 2019-02-01
• Primary Completion: 2019-07-30
• Status Verified: 2020-10
• Study Completion: 2020-10-06
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• Having undergone a radical prostatectomy surgical procedure.
• Presenting involuntary urine losses after radical prostatectomy intervention. (IU grade I, II or III)
• Do not exceed the year since the surgical intervention.
• Accept to participate in the study and grant signed informed consent.

Exclusion Criteria

• Follow a pharmacological treatment for the UI.
• Presenting anatomical malformations of the pelvic floor musculature.
• Carry pacemaker.
• Present anal fistulas.
• suffer from serious psychic disorders.
• Presenting lower urinary tract infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anal stimulation	Anal stimulation	Patient is asked to lie down with legs slightly bend and an electrical probe is inserted into the anus. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.
Transcutaneous perineal stimulation	Transcutaneous perineal stimulation	Patient is asked to lie down with legs slightly bend and two adhesive electrodes are attached transcutaneous on base of penis and on perineum. Stimulation current is administrated half time with a fixed frequency of 30 Hz and half time with 50 Hz. Pulse increased until the patient perceives the current. Sessions lasted for 30 minutes weekly for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Effects of transcutaneous perineal stimulation compared to anal stimulation	Baseline, 6 and 10 weeks	A change of the urine grams last in 24 hours

Secondary Outcome Measures

Name	Time	Method
Assess adverse effects	10 weeks	Identify adverse effects for each of the treatments
Asses quality of life	Baseline and 10 weeks	Asses the perceived quality of life of patients in the study. It will be evaluated with the questionnaire I-QOL. It measures the effect of urinary incontinence on quality of life.; The I-QOL have 22 items and is divided into 3 subscales: avoidance and limiting behavior, psychosocial impact, social embarrassment. More puntuation means more quality of life.

Trial Locations

Locations (1)

Regina Pané Alemany; 🇪🇸 Barcelona, Spain